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U.S. Department of Health and Human Services

Class 2 Device Recall Daytona Small Stature

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 Class 2 Device Recall Daytona Small Staturesee related information
Date Initiated by FirmOctober 29, 2024
Date PostedDecember 23, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0751-2025
Recall Event ID 95760
510(K)NumberK232566 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductBrand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
Code Information Lot Code: PN 79-0002 UDI 10889981185640 Lot Numbers MM1002742E, MM1003065E
Recalling Firm/
Manufacturer		 SEASPINE ORTHOPEDICS CORPORATION
5770 Armada Dr
Carlsbad CA 92008-4608
For Additional Information Contact
760-224-0177
Manufacturer Reason
for Recall		Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionUpdate 12/18/2024 - The firm sent an updated Customer Notification Letter on 12/12/2024 to customers that have not responded to the initial notification on 10/29/2024. On 10/29/2024, firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that the firm has identified a nonconformance with the threads of the locking cap components that may be incongruous with optimal manufacturing specifications. The nonconformance can result in a locking cap that does not mate appropriately with the screw tulip. Customers are instructed to: -Review their inventory and return the affected part(s) using the provided label to return the inventory in their possession. Any questions contact Dalton Daggs at Dalton.daggs@seaspine.com or Danielle Nelson-Archer at Danielle.nelson-archer@seaspine.com.
Quantity in Commerce92 devices
DistributionU.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NKB
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